Acutherapy for Joint Pain in Breast Cancer

Recruiting at 3 trial locations

Overseen By Demetria Smith-Graziani, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Emory University

Must be taking: Aromatase inhibitors

Must not be taking: CDK 4/6 inhibitors

Disqualifiers: Metastatic cancer, Rheumatoid arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether acupuncture or virtual acupressure (collectively called "Acutherapy") can manage joint pain caused by aromatase inhibitors in women with early-stage hormone receptor-positive breast cancer. Aromatase inhibitors block estrogen, crucial for treating this cancer type, but they can cause joint pain, leading some women to discontinue use. The trial compares in-person acupuncture, virtual acupressure, and standard treatment to determine which most effectively prevents this pain. Women who identify as Non-Hispanic Black, are postmenopausal, and have completed early-stage breast cancer treatment may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore alternative pain management options that could enhance quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should not have used adjuvant aromatase inhibitors for more than 14 days before the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that acupuncture safely manages joint pain caused by aromatase inhibitors in breast cancer patients. Research indicates it effectively reduces pain without major side effects. Similarly, self-applied acupressure helps with pain and tiredness in these patients, also without significant side effects.

Both acupuncture and acupressure are considered safe practices for managing symptoms like pain and tiredness, posing no serious risks. Participants in these studies generally experience only minor discomfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring acutherapy for joint pain in breast cancer patients because it offers a novel, non-pharmacological approach to managing discomfort. Unlike standard treatments that rely mainly on aromatase inhibitors, the acutherapy approach includes acupuncture and acupressure, which are believed to stimulate the body's natural pain-relief mechanisms. Acupuncture involves in-person sessions targeting specific points on the body, while acupressure allows patients to self-administer therapy virtually, providing flexibility and empowerment. These treatments potentially reduce reliance on medications, which can have side effects, making them an attractive option for enhancing the quality of life in patients.

What evidence suggests that acutherapy could be effective for preventing joint pain in breast cancer patients?

This trial will compare different approaches to managing joint pain in breast cancer patients undergoing aromatase inhibitor therapy. Research has shown that acupuncture, which participants in one arm of this trial will receive, can help reduce joint pain caused by aromatase inhibitors. In one study, women who received acupuncture reported less pain after 12 weeks, and the benefits lasted up to a year. Another review found acupuncture to be a safe and effective way to manage this joint pain. Meanwhile, participants in another arm will receive acupressure, which studies also indicate can help reduce joint pain in breast cancer patients. Both treatments seem promising in helping women continue their aromatase inhibitor therapy by easing joint pain. ^{1 2 6 7 8}

Who Is on the Research Team?

Demetria Smith-Graziani, MD,MPH

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

This trial is for Non-Hispanic Black postmenopausal women with stage I-III hormone receptor positive breast cancer who are taking aromatase inhibitors. It aims to help those suffering from joint pain due to their medication. Participants should not have started AI therapy more than a month ago and must be able to attend in-person or virtual sessions.

Inclusion Criteria

I am a Non-Hispanic Black woman.

I am postmenopausal.

I have early to mid-stage breast cancer that is hormone receptor positive and HER2 negative.

Exclusion Criteria

History of allergic reactions attributed to compounds of similar chemical or biologic composition to acupuncture needles or other agents used in study

I have been diagnosed with rheumatoid arthritis, multiple sclerosis, or muscular dystrophy.

I have been diagnosed with breast cancer that has spread.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either in-person acupuncture or virtual acupressure therapy while receiving standard of care AI therapy

12 weeks

Twice weekly for the first 6 weeks, then once weekly for 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Acutherapy

Trial Overview The study tests if acupuncture (inserting thin needles into the skin) or acupressure (applying pressure on specific body points) can prevent joint pain caused by aromatase inhibitor therapy in participants. The effectiveness of these complementary therapies will be compared through surveys and discussions.

How Is the Trial Designed?

Group I: Arm II (acupressure, AI therapy) Experimental Treatment 4 Interventions

Patients undergo self-administered acupressure therapy virtually over 1 hour twice weekly for the first 6 weeks and then once weekly for 6 weeks and receive SOC AI therapy.

Group II: Arm I (acupuncture, AI therapy) Experimental Treatment 4 Interventions

Patients undergo acupuncture therapy in-person over 1 hour twice weekly for the first 6 weeks and then once weekly for 6 weeks and receive standard of care (SOC) aromatase inhibitor (AI) therapy.

Group III: Arm III (AI therapy) Active Control 2 Interventions

Patients receive SOC AI therapy.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Shoulder pain and joint dysfunction are common side effects after breast cancer treatment, affecting 12% to 51% of patients, highlighting the need for effective physiotherapy interventions.

Targeted physiotherapy, including active exercises and multidisciplinary approaches, is essential for managing different types of shoulder pain in breast cancer survivors, with a focus on supervised exercise programs for optimal recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Physiotherapy Intervention for Shoulder Pain in Patients Treated for Breast Cancer: Systematic Review. Giacalone, A., Alessandria, P., Ruberti, E.[2020]

A pilot study involving 32 postmenopausal women with early breast cancer showed that acupuncture is feasible and safe for treating joint pain caused by aromatase inhibitors, with no serious adverse events reported.

While the study did not find significant differences in pain and stiffness outcomes, there were positive trends favoring real electroacupuncture in improving stiffness and physical function at 12 weeks, suggesting potential benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for treatment of arthralgia secondary to aromatase inhibitor therapy in women with early breast cancer: pilot study. Oh, B., Kimble, B., Costa, DS., et al.[2013]

Acupuncture significantly reduced joint pain and improved functional ability in postmenopausal women undergoing aromatase inhibitor therapy for breast cancer, with pain scores decreasing from 5.3 to 3.3 after treatment.

The study involved 21 women and showed no adverse events, indicating that acupuncture is a safe and well-tolerated option for alleviating AI-induced arthralgias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of acupuncture for the treatment of joint symptoms related to adjuvant aromatase inhibitor therapy in postmenopausal breast cancer patients. Crew, KD., Capodice, JL., Greenlee, H., et al.[2022]

Acupuncture significantly reduces joint pain in patients experiencing aromatase inhibitor-induced arthralgia, with notable improvements observed after 6-8 weeks of treatment, as indicated by reductions in pain scores from the Brief Pain Inventory and WOMAC.

The treatment is considered safe, with only 18 minor adverse events reported among 181 patients across five trials, suggesting that acupuncture is a viable nonpharmacologic option for managing pain associated with breast cancer hormonal therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of acupuncture on aromatase inhibitor-induced arthralgia in patients with breast cancer: A meta-analysis of randomized controlled trials. Chen, L., Lin, CC., Huang, TW., et al.[2022]

Acupuncture may be a safe and promising complementary treatment for arthralgia in breast cancer patients taking aromatase inhibitors, as suggested by three out of five reviewed randomized clinical trials showing favorable effects on pain and joint symptoms.

However, the meta-analysis indicated that the differences in pain and stiffness between acupuncture and sham treatment were not statistically significant, highlighting the need for further research with additional outcome measures to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for treating aromatase inhibitor-related arthralgia in breast cancer: a systematic review and meta-analysis. Chien, TJ., Liu, CY., Chang, YF., et al.[2022]

Chemotherapy-related arthropathy is a common issue among breast cancer patients, with joint symptoms typically starting around 6 months after treatment begins, affecting 15 women in this study.

Most patients (13 out of 15) experienced significant improvement in symptoms after about 3 months of treatment with medications like NSAIDs and corticosteroids, with 9 patients achieving complete resolution of their symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of patients with post-chemotherapy arthralgia and arthritis in breast cancer. Amiri, AH., Rafiei, A.[2022]

In a survey of 424 breast cancer patients experiencing joint pain, 16% reported using acupuncture since their diagnosis, indicating a notable interest in alternative pain management options.

Patients with higher levels of pain catastrophising, particularly those who ruminate or magnify their pain experiences, were more likely to seek acupuncture treatment, suggesting that psychological factors may influence the use of this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cross-sectional survey of pain catastrophising and acupuncture use among breast cancer survivors. Lee, I., Garland, SN., DeMichele, A., et al.[2019]

In a study of 23 women with breast cancer, many developed new rheumatic symptoms after treatment, with significant impacts on their functional status; this included conditions like polyarthritis and fibromyalgia, particularly during or after chemotherapy and tamoxifen therapy.

Women with a prior history of rheumatic symptoms were more likely to experience worsening symptoms after breast cancer treatment, highlighting the need for further research to understand the incidence and management of these conditions in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rheumatic symptoms following adjuvant therapy for breast cancer. Warner, E., Keshavjee al-N, ., Shupak, R., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11753630/

Self-acupressure for patients with breast cancer experiencing ... A linear model with the outcome being weekly worst joint pain scores from week 1 to 12 using generalized estimating equations with robust ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06534125?draw=2&rank=1

NCT06534125 | Acutherapy to Prevent Aromatase Inhibitor ... AI therapy prolongs life among patients with early-stage HR+ breast cancer. Many postmenopausal women stop AI therapy early due to debilitating joint pain ( ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2811822

Acupuncture vs Massage for Pain in Patients Living With ... In this randomized clinical trial that included 298 patients with advanced cancer, both acupuncture and massage were associated with long-term pain reduction.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39841658/

Self-acupressure for patients with breast cancer ... Background: Aromatase inhibitors (AI) reduce hormone receptor-positive breast cancer recurrence risk by about 50%.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7883140/

Acupuncture for Arthralgia Induced by Aromatase Inhibitors in ... This meta-analysis showed that acupuncture is a safe and effective treatment for breast cancer patients with AIA.

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-04392

Acupuncture or Acupressure for the Prevention of ... AI therapy prolongs life among patients with early-stage HR+ breast cancer. Many postmenopausal women stop AI therapy early due to debilitating joint pain ( ...

7. trials.arthritis.org trials.arthritis.org/trials/NCT06534125

Acutherapy to Prevent Aromatase Inhibitor-Associated ... This clinical trial evaluates if in-person acupuncture or virtual acupressure therapy prevents aromatase inhibitor-associated joint pain in Non-Hispanic Black ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04927910

Self-applied Acupressure for Arthralgia-fatigue-sleep ... Subjects will include 52 breast cancer survivors who are receiving aromatase inhibitors and have experienced a moderate level of joint pain and at least one of ...